You will coordinate batch record flow and perform reviews of manufacturing paperwork to ensure regulatory compliance. Detailed knowledge of CGMP, aseptic practices, data integrity, and GDP is required for this role. A bachelor’s degree in science is preferred, and a minimum of 2 years of experience in a similar role is required. You must be in the office on Tuesday, Wednesday, and Thursday, with the flexibility to work remotely on Mondays and Fridays.
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AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Job Description
We are now recruiting an experienced Manufacturing Analyst and Documentation Coordinator to join our Core 1 Operations team in AbbVie Westport, Co Mayo on a fixed term contract.
In the role, you will have the opportunity to coordinate batch record flow, corrections, manufacturing status tracking spreadsheets, report preparation, Complaints tracking. The successful candidate will perform reviews of manufacturing and other paperwork to ensure compliance to Abbvie and regulatory standards. The manufacturing analyst will be required to communicate up to date status reviews and work with Manufacturing Technicians, Technical Writers and Technical Shift leads to coordinate and ensure the completion of manufacturing batch paperwork.
If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:
Key activities:
Compile and perform manufacturing audit review of batch paperwork from manufacturing areas.
Ensure all batch records components are present and that all corrections identified during initial review and by Product Release Team are addressed in a timely and compliant manner.
Use and maintenance of data within key systems such as SAP, S4HANA.
Document retrieval from local files and archives, as required for submissions, customer requests and others.
Participate in non-conformance and exception investigations as necessary.
Work with QA Teams to align and promote awareness on data integrity and good documentation practices.
Facilitate and coordinate with project teams to enhance, improve and streamline batch records.
Management of purchasing requisitions.
Provide assistance when required at Regulatory Inspections.
Trending and c-ordination of customer complaints investigations.
Work close with Depts on corrective actions arising from Environmental excursions.
Comply with Abbvie policies and procedures and regulatory agency regulations.
Qualifications
Bachelor’s degree in science, or a related field is preferred and/or a minimum of 2 years’ experience in a similar role.
Detailed knowledge of CGMP and aseptic practices, data integrity requirements and GDP is required for this role.
Strong organizational skills and attention to detail are essential for this role.
Good interpersonal relations/communications skills
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Pay Range: $
Where We Work
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.
